DCBBOSSNCT06247982
Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions
An observational study of DCB and De Novo Stenosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is: if BOS PCI leads to an higher rate of 1-year… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DCB, De Novo Stenosis, PCI
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2023to 28 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All de novo DCB PCI ≥ 18 years-old patients who meet inclusion/exclusion criteria.
Who may be able to join
- De novo DCB PCI of at least one coronary artery
- Hybrid PCI of bifurcation (main branch stent and side branch DCB)
- Hybrid PCI of coronary artery with more than one stenosis (at least 10 mm of distance between edge of stent and DCB PCI segment)
Who cannot join
- in-stent restenosis
- more than 1 year life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions: the BOSS Study
The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is:
- if BOS PCI leads to an higher rate of 1-year target vessel failure that DCB-only PCI.
Read more
Participants will receive DCB PCI in de novo coronary stenosis. Treatments they\'ll be given should be:
- DCB-only PCI
- BOS PCI
Researchers will compare DCB-only and BOS group to see if addictive stent implantation for DCB-PCI complication is relate to an higher rate of target vessel failure.
Target vessel is the primary endpoint, defined as:
- cardiovascular death
- target vessel myocardial infarction
- clinical driven target vessel revascularization
- angiographic restenosis
Read the detailed description
Drug coated balloon (DCB) percutaneous coronary intervention (PCI) has been shown to be as effective as last generation drug eluting stent (DES) PCI in many randomized trials. However a not negligible rate of patients must receive a bail-out stenting (BOS) implantation after DCB-PCI. Only some studies report that the rate of MACE of these patients is higher than DCB-only or DES-PCI ones. Even if the BOS patients MACE rate is two times more than DCB-only or DES-only, due to the small amount of BOS patients in these studies there were not a statistically significant difference.
According to these evidence, BOSS study researchers will compare target vessel failure (TVF) rate in DCB-only and BOS group resulting from all vessel size de novo coronary artery stenosis DCB-PCI.
TVF as primary endpoint will include:
- cardiovascular death
- target vessel myocardial infarction (TV-MI). According to the third universal definition of myocardial infarction TV-MI will be considered a non fatal myocardial infarction with the evidence of myocardial necrosis in the vascular territory of previously treated target vessel
- clinical driven target vessel revascularization (CD-TVR). CD-TVR will be considered as any repeat intervention of any segment of the target vessel, defined as the entire major coronary vessel proximal and distal to the target lesion.
- Angiographic restenosis. It will considered in case of restenosis as either a \> 50% loss of initial gain of the target lesion.
The trial will enroll all patients who received a de novo DCB-PCI from January 2020 to December 2023. The population will be divided into two groups:
- DCB-only PCI
- BOS PCI
Bail-out stenting will be done in case of high grade coronary dissection (\> or equal to NHLBI grade C) or in case of \> 30% recoil, according with International DCB Consensus.
- Conditions
- DCB, De Novo Stenosis, PCI
- Keywords
- DCB, PCI, de novo, Bail-out stenting, TVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DCB de novo PCI | All patients who received a de novo DCB PCI | |
| BOS PCI | All patients who received a stent after DCB treatment of de novo coronary lesion because of high grade dissection or recoil more than 30% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure of de novo PCI
Number of patients with the composite endpoint (number of cardiovascular death, TV-MI, CD-TVR, angiographic restenosis)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start6 Nov 2023
- Primary completion28 Jan 2025
- Study completion28 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCBStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Ghetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247982
- Sponsor's protocol ID
- BOSS study
- Acronym
- BOSS
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions: the BOSS Study
- ClinicalTrials.gov ID
- NCT06247982
- Acronym / sponsor ID
- BOSS / BOSS study
- Conditions
- DCB, De Novo Stenosis, PCI
- Keywords
- DCB, PCI, de novo, Bail-out stenting, TVF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is:
- if BOS PCI leads to an higher rate of 1-year target vessel failure that DCB-only PCI.
Participants will receive DCB PCI in de novo coronary stenosis. Treatments they\'ll be given should be:
- DCB-only PCI
- BOS PCI
Researchers will compare DCB-only and BOS group to see if addictive stent implantation for DCB-PCI complication is relate to an higher rate of target vessel failure.
Target vessel is the primary endpoint, defined as:
- cardiovascular death
- target vessel myocardial infarction
- clinical driven target vessel revascularization
- angiographic restenosis
Detailed description
Drug coated balloon (DCB) percutaneous coronary intervention (PCI) has been shown to be as effective as last generation drug eluting stent (DES) PCI in many randomized trials. However a not negligible rate of patients must receive a bail-out stenting (BOS) implantation after DCB-PCI. Only some studies report that the rate of MACE of these patients is higher than DCB-only or DES-PCI ones. Even if the BOS patients MACE rate is two times more than DCB-only or DES-only, due to the small amount of BOS patients in these studies there were not a statistically significant difference.
According to these evidence, BOSS study researchers will compare target vessel failure (TVF) rate in DCB-only and BOS group resulting from all vessel size de novo coronary artery stenosis DCB-PCI.
TVF as primary endpoint will include:
- cardiovascular death
- target vessel myocardial infarction (TV-MI). According to the third universal definition of myocardial infarction TV-MI will be considered a non fatal myocardial infarction with the evidence of myocardial necrosis in the vascular territory of previously treated target vessel
- clinical driven target vessel revascularization (CD-TVR). CD-TVR will be considered as any repeat intervention of any segment of the target vessel, defined as the entire major coronary vessel proximal and distal to the target lesion.
- Angiographic restenosis. It will considered in case of restenosis as either a \> 50% loss of initial gain of the target lesion.
The trial will enroll all patients who received a de novo DCB-PCI from January 2020 to December 2023. The population will be divided into two groups:
- DCB-only PCI
- BOS PCI
Bail-out stenting will be done in case of high grade coronary dissection (\> or equal to NHLBI grade C) or in case of \> 30% recoil, according with International DCB Consensus.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB de novo PCI | – | –All patients who received a de novo DCB PCI |
| BOS PCI | – | –All patients who received a stent after DCB treatment of de novo coronary lesion because of high grade dissection or recoil more than 30% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All de novo DCB PCI ≥ 18 years-old patients who meet inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- De novo DCB PCI of at least one coronary artery
- Hybrid PCI of bifurcation (main branch stent and side branch DCB)
- Hybrid PCI of coronary artery with more than one stenosis (at least 10 mm of distance between edge of stent and DCB PCI segment)
Key exclusion criteria (2 listed)
- in-stent restenosis
- more than 1 year life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target Vessel Failure of de novo PCI
Time frame: 1 year
Number of patients with the composite endpoint (number of cardiovascular death, TV-MI, CD-TVR, angiographic restenosis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
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Virtue® SAB in the Treatment of Coronary ISR Trial
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Active, not recruiting
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
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AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Ghetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DCB and De Novo Stenosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure of de novo PCI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.